MAUDE Adverse Event Report: COVIDIEN PARIETEX OPTIMIZED COMPOSITE MESH (PCO)

Model Number PCO15100SX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Miscarriage (1962); Hernia (2240); Therapeutic Response, Decreased (2271); Test Result (2695)

Event Date 09/28/2013

Event Type  Injury  

Event Description

Hernia repair with the mesh on (b)(6) 2013 in (b)(6) hospital.Three days later, i went to take a bath, then i noted the hernia was sticking straight out of my stomach.Then i went to the hospital.They rushed me back to (b)(6).The xray, did an ultrasound.Said it was the hernia sticking out.Sent me back to the doctor.The doctor turned me down.I hurt really bad all the time.It took me a year and a half to find another doctor, and it made me lose my baby.Three and half months, it was a tube pregnancy.The doctor told me i would have to have surgery to take the mesh out because it didn't hold.It has caused me too many problems and pain.Please help before somebody else has to go through the same thing.This has messed my life up.Please don't let it happen to nobody else.

• Brand Name: PARIETEX OPTIMIZED COMPOSITE MESH (PCO)
• Type of Device: MESH
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 5335126
• MDR Text Key: 34689919
• Report Number: MW5058790
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/01/2014
• Device Model Number: PCO15100SX
• Device Catalogue Number: PCO15100SX
• Device Lot Number: PME00335
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CONCEPT DHA
• Patient Outcome(s): Congenital Anomaly; Death; Required Intervention